Trial to Test the Effectiveness of Vibrotactile Stimulation for Lower Limb Spasticity

Vibrotactile Stimulation for Lower Limb Spasticity

The goal of this clinical trial is to find out if Vibrotactile Stimulation (VTS) can help improve mobility and reduce spasticity (muscle stiffness) in people with lower limb spasticity. The study will also look at how VTS affects walking speed. The main questions it aims to answer are:

• Which areas of the body are the best for applying VTS?
• Does VTS help improve walking speed in people with lower limb spasticity?

Participants will:

• Receive 15 minutes of VTS treatment on different parts of the body
• Use the VTS device for 60 minutes during supervised lab sessions and at home (at rest and while walking)
• Complete a daily log of how much time the device was used for and note any issues or difficulties the participant experience
• Complete assessments after the treatment to measure change in mobility
• Complete surveys about how comfortable the device is to use

Study Overview

• Status: Not yet recruiting
• Conditions: Lower Limb Spasticity
• Intervention / Treatment: Device: Vibrotactile Stimulation (Static Use); Device: Vibrotactile Stimulation (Dynamic Use); Device: Vibrotactile Stimulation (Neurophysiological Mechanism)

Detailed Description

This study will investigate both the neurophysiological mechanisms and clinical effects of VTS in individuals with poststroke lower limb spasticity.

Aim 1 will assess how different anatomical placements of VTS impact neuromuscular activity and spasticity.

Aim 2 will test the feasibility and efficacy of VTS during both static and dynamic gait contexts using a randomized crossover design.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Department of Rehabilitation Medicine
      • Contact: Joan Stilling, MD., MS.; Phone Number: 212-746-1500; Email: qsi9001@med.cornell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ≥6 months following neurologic diagnosis leading to spasticity
• Modified Ashworth Scale (MAS) score of 3 or lower on ankle plantar flexor.
• Ability to stand (with or without assistance) and lie supine.
• Able to understand and comply with study procedures.

Exclusion Criteria:

• Uncontrolled systemic illness or serious medical conditions that could interfere with study procedures.
• Previous surgery to treat spasticity in the affected lower limb.
• Prior Botulinum Toxin (BoNT) therapy in the target limb within 4 months.
• Unstable medication regimens for spasmolysis or muscle relaxation.
• Participation in tone-related treatments (e.g., physiotherapy, TENS, acupuncture) within 4 weeks prior to baseline. If ongoing treatment started more than 4 weeks before baseline, it should remain consistent throughout the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VTS Static Use, then Dynamic Use (Aim 2); The participant will first use the VTS device for 60 minutes daily for three consecutive days while in a static position. After a washout period of 1 week, the participant will use the VTS device for 60 minutes daily for three consecutive days during active gait training.	Device: Vibrotactile Stimulation (Static Use); The Vibrotactile Stimulation (VTS) device is a wearable, non-invasive therapeutic system designed to reduce spasticity and improve motor function in individuals with neurological impairments leading to lower limb spasticity. The device consists of a compact vibratory motor housed in a soft, adjustable strap that can be worn over targeted muscle groups (e.g., gastrocnemius/soleus complex). The stimulation is delivered at a predefined frequency and amplitude, optimized based on prior research to modulate spinal reflex pathways and reduce motoneuron hyperexcitability. The device will be worn during static conditions (e.g., standing or seated) and is intended for daily use at home or in-clinic.
Experimental: VTS Dynamic Use, then Static Use (Aim 2); The participant will first use the VTS device for 60 minutes daily for three consecutive days during active gait training. After a washout period of 1 week, the participant will use the VTS device for 60 minutes daily for three consecutive days while in a static position.	Device: Vibrotactile Stimulation (Dynamic Use); The Vibrotactile Stimulation (VTS) device is a wearable, non-invasive therapeutic system designed to reduce spasticity and improve motor function in individuals with neurological impairments leading to lower limb spasticity. The device consists of a compact vibratory motor housed in a soft, adjustable strap that can be worn over targeted muscle groups (e.g., gastrocnemius/soleus complex). The stimulation is delivered at a predefined frequency and amplitude, optimized based on prior research to modulate spinal reflex pathways and reduce motoneuron hyperexcitability. The device will be used in dynamic conditions (e.g., walking) and is intended for daily use at home or in-clinic.
Other: VTS Neurophysiological Mechanism (Aim 1); The participant will use the VTS device for three 15-minutes sessions, once for each anatomical locations (i.e. muscle belly, origin, and insertion) around the leg and ankle.	Device: Vibrotactile Stimulation (Neurophysiological Mechanism); The Vibrotactile Stimulation (VTS) device is a wearable, non-invasive therapeutic system designed to reduce spasticity and improve motor function in individuals with neurological impairments leading to lower limb spasticity. The device consists of a compact vibratory motor housed in a soft, adjustable strap that can be worn over targeted muscle groups (e.g., gastrocnemius/soleus complex). The stimulation is delivered at a predefined frequency and amplitude, optimized based on prior research to modulate spinal reflex pathways and reduce motoneuron hyperexcitability. The device will be used to investigate the neurophysiological mechanisms through which VTS modulates spasticity at different anatomical sites and its effectiveness on improving mobility. investigate the underlying neurophysiological mechanisms through which VTS modulates spasticity and muscle tone at different anatomical locations (i.e. muscle belly, origin, and insertion) around the leg and ankle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
H-reflex amplitude Baseline (Aim 1)	Assesses spinal reflex excitability as a neurophysiological indicator of spasticity modulation. μV amplitude; no fixed range.	Baseline measurement immediately before three 15-minutes intervention periods within a single session (Day 1) for Aim 1
H-reflex amplitude After Intervention (Aim 1)	Assesses spinal reflex excitability as a neurophysiological indicator of spasticity modulation. μV amplitude; no fixed range.	Immediately after each of three 15-minutes intervention periods within a single session (Day 1) for Aim 1
Surface EMG activity of gastrocnemius/soleus Baseline (Aim 1)	Measures muscle activation patterns in gastrocnemius/soleus to evaluate VTS effects. μV amplitude; no fixed range.	Baseline measurement immediately before three 15-minutes intervention periods within a single session (Day 1) for Aim 1
Surface EMG activity of gastrocnemius/soleus After Intervention (Aim 1)	Measures muscle activation patterns in gastrocnemius/soleus to evaluate VTS effects. μV amplitude; no fixed range.	Immediately after each of three 15-minutes intervention periods within a single session (Day 1) for Aim 1
Modified Ashworth Scale at Screening	Assesses muscle tone and spasticity, especially in ankle plantarflexors.Total score ranges from: 0 (no increase in tone) to 4 (rigid in flexion/extension).	Screening Visit (-0 to 7 days prior to Aim 1 intervention)
Modified Ashworth Scale at Baseline (Aim 1)	Assesses muscle tone and spasticity, especially in ankle plantarflexors.Total score ranges from: 0 (no increase in tone) to 4 (rigid in flexion/extension).	Baseline measurement immediately before three 15-minutes intervention periods within a single session (Day 1) for Aim 1
Modified Ashworth Scale After Intervention (Aim 1)	Assesses muscle tone and spasticity, especially in ankle plantarflexors.Total score ranges from: 0 (no increase in tone) to 4 (rigid in flexion/extension).	Immediately after each of three 15-minutes intervention periods within a single session (Day 1) for Aim 1
Modified Ashworth Scale at Baseline (Aim 2)	Assesses muscle tone and spasticity, especially in ankle plantarflexors.Total score ranges from: 0 (no increase in tone) to 4 (rigid in flexion/extension).	Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Modified Ashworth Scale After Intervention (Aim 2)	Assesses muscle tone and spasticity, especially in ankle plantarflexors.Total score ranges from: 0 (no increase in tone) to 4 (rigid in flexion/extension).	Immediately after intervention for 3 consecutive days for Aim 2
Passive range of motion at the ankle at Screening	Evaluates joint flexibility, particularly at the ankle. Range:Degrees; higher indicates greater flexibility	Screening Visit (-0 to 7 days prior to Aim 1 intervention)
Passive range of motion at the ankle at Baseline (Aim 1)	Evaluates joint flexibility, particularly at the ankle. Range:Degrees; higher indicates greater flexibility	Baseline measurement immediately before three 15-minutes intervention periods within a single session (Day 1) for Aim 1
Passive range of motion at the ankle After Intervention (Aim 1)	Evaluates joint flexibility, particularly at the ankle. Range:Degrees; higher indicates greater flexibility	Immediately after each of three 15-minutes intervention periods within a single session (Day 1) for Aim 1
Passive range of motion at the ankle at Baseline (Aim 2)	Evaluates joint flexibility, particularly at the ankle. Range:Degrees; higher indicates greater flexibility	Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Passive range of motion at the ankle After Intervention (Aim 2)	Evaluates joint flexibility, particularly at the ankle. Range:Degrees; higher indicates greater flexibility	Immediately after intervention for 3 consecutive days for Aim 2
10 meter walk test at Baseline (Aim 2)	Measures gait speed over a short distance; primary measure of functional mobility. Time is in seconds; lower is better.	Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
10 meter walk test at Baseline After Intervention (Aim 2)	Measures gait speed over a short distance; primary measure of functional mobility. Time is in seconds; lower is better.	Immediately after intervention for 3 consecutive days for Aim 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed up and go (TUG) at Baseline (Aim 2)	Assesses walking endurance and functional mobility over a longer duration.Distance in meters; higher is better.	Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Timed up and go (TUG) After Intervention (Aim 2)	Assesses walking endurance and functional mobility over a longer duration.Distance in meters; higher is better.	Immediately after intervention for 3 consecutive days for Aim 2
Two minute walk test (TMWT) at Baseline (Aim 2)	Assesses functional mobility, balance, and fall risk. Time (s); lower is better.	Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Two minute walk test (TMWT) After Intervention (Aim 2)	Assesses functional mobility, balance, and fall risk. Time (s); lower is better.	Immediately after intervention for 3 consecutive days for Aim 2
Berg Balance Scale (BBS) at Baseline (Aim 2)	Evaluates balance performance using a 14-item scale. Range: 0 to 56; higher scores indicate better balance.	Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Berg Balance Scale (BBS) After Intervention (Aim 2)	Evaluates balance performance using a 14-item scale. Range: 0 to 56; higher scores indicate better balance.	Immediately after intervention for 3 consecutive days for Aim 2
Global Impression of Change Scale (GICS) at Baseline (Aim 2)	Self-reported measure of overall perceived improvement. Range: 1 (very much worse) to 7 (very much improved.	Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Global Impression of Change Scale (GICS) After Intervention (Aim 2)	Self-reported measure of overall perceived improvement. Range: 1 (very much worse) to 7 (very much improved.	Immediately after intervention for 3 consecutive days for Aim 2
Short form 12 (SF12) at Baseline (Aim 2)	Assesses health-related quality of life across physical and mental domains. Range: 0 to 100 per domain; higher is better	Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Short form 12 (SF12) After Intervention (Aim 2)	Assesses health-related quality of life across physical and mental domains. Range: 0 to 100 per domain; higher is better	Immediately after intervention for 3 consecutive days for Aim 2

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Joan Stilling, M.D., M.S., Weill Medical College of Cornell University

Publications and helpful links

General Publications

• Khalifeloo M, Naghdi S, Ansari NN, Akbari M, Jalaie S, Jannat D, Hasson S. A study on the immediate effects of plantar vibration on balance dysfunction in patients with stroke. J Exerc Rehabil. 2018 Apr 26;14(2):259-266. doi: 10.12965/jer.1836044.022. eCollection 2018 Apr.
• Caliandro P, Celletti C, Padua L, Minciotti I, Russo G, Granata G, La Torre G, Granieri E, Camerota F. Focal muscle vibration in the treatment of upper limb spasticity: a pilot randomized controlled trial in patients with chronic stroke. Arch Phys Med Rehabil. 2012 Sep;93(9):1656-61. doi: 10.1016/j.apmr.2012.04.002. Epub 2012 Apr 13.
• Seo NJ, Woodbury ML, Bonilha L, Ramakrishnan V, Kautz SA, Downey RJ, Dellenbach BHS, Lauer AW, Roark CM, Landers LE, Phillips SK, Vatinno AA. TheraBracelet Stimulation During Task-Practice Therapy to Improve Upper Extremity Function After Stroke: A Pilot Randomized Controlled Study. Phys Ther. 2019 Mar 1;99(3):319-328. doi: 10.1093/ptj/pzy143.
• Seim CE, Wolf SL, Starner TE. Wearable vibrotactile stimulation for upper extremity rehabilitation in chronic stroke: clinical feasibility trial using the VTS Glove. J Neuroeng Rehabil. 2021 Jan 23;18(1):14. doi: 10.1186/s12984-021-00813-7.
• Seim CE, Ritter B, Starner TE, Flavin K, Lansberg MG, Okamura AM. Design of a Wearable Vibrotactile Stimulation Device for Individuals With Upper-Limb Hemiparesis and Spasticity. IEEE Trans Neural Syst Rehabil Eng. 2022;30:1277-1287. doi: 10.1109/TNSRE.2022.3174808. Epub 2022 May 17.
• Kodama K, Yasuda K, Kuznetsov NA, Hayashi Y, Iwata H. Balance Training With a Vibrotactile Biofeedback System Affects the Dynamical Structure of the Center of Pressure Trajectories in Chronic Stroke Patients. Front Hum Neurosci. 2019 Mar 12;13:84. doi: 10.3389/fnhum.2019.00084. eCollection 2019.
• Farì, G. (2023). Is there a new road to spinal cord injury rehabilitation? a case report about the effects of driving a go-kart on muscle spasticity. Diseases, 11(3), 107. https://doi.org/10.3390/diseases11030107
• Enders LR, Hur P, Johnson MJ, Seo NJ. Remote vibrotactile noise improves light touch sensation in stroke survivors' fingertips via stochastic resonance. J Neuroeng Rehabil. 2013 Oct 11;10:105. doi: 10.1186/1743-0003-10-105.
• Bark K, Hyman E, Tan F, Cha E, Jax SA, Buxbaum LJ, Kuchenbecker KJ. Effects of vibrotactile feedback on human learning of arm motions. IEEE Trans Neural Syst Rehabil Eng. 2015 Jan;23(1):51-63. doi: 10.1109/TNSRE.2014.2327229. Epub 2014 Jun 2.
• Alashram, A. and Annino, G. (2022). Focal muscle vibration reduces spasticity and improves functional level in incomplete spinal cord injury: a case report. Physikalische Medizin Rehabilitationsmedizin Kurortmedizin, 33(03), 162-165. https://doi.org/10.1055/a-1819-6874
• Afzal, M., Pyo, S., Oh, M., Park, S., & Yoon, J. (2018). Evaluating the effects of delivering integrated kinesthetic and tactile cues to individuals with unilateral hemiparetic stroke during overground walking. Journal of Neuroengineering and Rehabilitation, 15(1). https://doi.org/10.1186/s12984-018-0372-0
• Afzal, M., Lee, H., Eizad, A., Lee, C., Oh, M., & Yoon, J. (2019). Effects of vibrotactile biofeedback coding schemes on gait symmetry training of individuals with stroke. Ieee Transactions on Neural Systems and Rehabilitation Engineering, 27(8), 1617-1625. https://doi.org/10.1109/tnsre.2019.2924682

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: stroke; gait; quality of life; lower limb; mobility; spasticity; walking endurance; home device; vts; LLS
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscle Spasticity; Stroke
• Other Study ID Numbers: 25-07029051; UL1TR002384 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified participant-level data including demographic information, baseline and post-intervention assessments of spasticity, EMG/H-reflex measures, and functional outcomes (e.g., 10-Meter Walk Test, Modified Ashworth Scale). No direct identifiers or protected health information will be included.
• IPD Sharing Time Frame: Following publication of the primary outcomes manuscript and completion of all planned analyses. Data will be available for up to 6 years after study completion.
• IPD Sharing Access Criteria: Qualified investigators affiliated with academic, clinical, or non-profit research institutions who submit a scientifically sound proposal consistent with the aims of the original study. Data will be made available through a controlled access process. Interested researchers should contact the Principal Investigator via institutional email. Approved applicants must sign a Data Use Agreement outlining terms of use, data protection requirements, and agreement to destroy data after the completion of approved analyses.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes